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Basaglar
insulin glargine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Basaglar
Proper name
insulin glargine
Licence type
351(a)
BLA number
205692
Applicant
Eli Lilly and Company
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | December 16, 2015 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | November 15, 2019 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |